HeRO symphony 3.1

by Medical Predictive Science Corp.

Ref 100000Model symphony

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00865536000203 Basic UDI-DI 00865536000203UDI-DI	Date1 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00865536000203 UDI-DI	Date29 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: HeRO EUDAMED
HeRO symphony GUDID
Generic Name: Neonatal/paediatric heart rate monitoring hardware
Model / Reference: symphony EUDAMED
100000 EUDAMED
3.1 GUDID

Primary DI / UDI-DI: 00865536000203
Basic UDI-DI: B-00865536000203
510(k) Number: K180242
FDA Product Code: DPS
EMDN Code: V0299 Neonatology and paediatric devices - other
GMDN Term: Neonatal/paediatric heart rate monitoring hardware

Device Class: Class IIb EUDAMED
Class II GUDID
Regulation Number: 870.2340
Special Device Type: -1192
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / Reference	EUDAMED symphony 100000	GUDID 3.1
Device Class	EUDAMED Class IIb	GUDID Class II

Other devices from Medical Predictive Science Corp.

HeRO solo 3.1

Class II
HeRO ES 3.1

Class II
HeRO duet 3.1

Class II
HeRO Symphony, HeRO ES, HeRO solo/duet

Class II
HeRO

Class II
HERO, Version 2.0

Class II

Properties

Lot / Batch Number
Manufacturing Date

Other properties (20)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No